Agilus
Authorised
This medicine is authorised for use in the European Union
dantrolene sodium, hemiheptahydrate
MedicineHumanAuthorised
Overview
Agilus is a medicine used to treat malignant hyperthermia (rapid rise in body temperature caused by uncontrolled muscle contractions) in adults and children. Malignant hyperthermia is a serious reaction to certain medicines used for general anaesthesia during surgery or other medical procedures.
Agilus contains the active substance dantrolene and is a ‘hybrid medicine’. This means that it is similar to a reference medicine containing the same active substance, but there are certain differences between the two. Agilus contains a higher amount of the active substance than the reference medicine, and also contains different excipients (ingredients) that make the powder easier to dissolve. The reference medicine for Agilus is Dantrium IV.
The medicine can only be obtained with a prescription. It is available as a powder to be made up into a solution for injection into a vein.
For more information about using Agilus, see the package leaflet or contact your doctor or pharmacist.
Malignant hyperthermia involves a very high body temperature and uncontrolled muscle contractions. The active substance in Agilus, dantrolene, attaches to a receptor (target) called the ryanodine receptor, which is involved in the contraction of skeletal muscles (muscles involved in movement) by releasing calcium in the skeletal muscle cells. By binding to this receptor, dantrolene blocks calcium release, thereby helping the muscles to relax and improving the symptoms of malignant hyperthermia.
As for every medicine, the company provided studies on the quality of Agilus, as well as published literature on the safety of the new excipients. The company also carried out a study that showed that Agilus is ‘bioequivalent’ to the reference medicine, Dantrium IV. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.
Because dantrolene is a well-established substance that has been used for many decades in the EU, the company provided data from the scientific literature on the benefits and risks of dantrolene in the treatment of malignant hyperthermia in adults and children.
For the full list of side effects and restrictions with Agilus, see the package leaflet.
The most common side effect with Agilus is skeletal muscle weakness, which is linked to the way the medicine works. The frequency of this side effect is not known because not enough data are available.
Malignant hyperthermia is a rare but serious condition that requires rapid treatment. Agilus has been shown to be bioequivalent to another medicine authorised for the condition, but it contains different excipients which allow it to be prepared and given more quickly and in a lower volume of fluid. There is some uncertainty about the possible negative effect of one of the excipients, hydroxypropyl beta-cyclodextrin (HP-β-CD), on hearing. However, the European Medicines Agency noted that the few cases of hearing loss reported in patients who were treated with HP-β-CD for a different condition were mostly mild and short-lasting.
The Agency therefore decided that Agilus’s benefits are greater than its risks and that it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Agilus have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Agilus are continuously monitored. Suspected side effects reported with Agilus are carefully evaluated and any necessary action taken to protect patients.
Agilus received a marketing authorisation valid throughout the EU on 29 May 2024.
Product information
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Agilus
- Active substance
- dantrolene sodium, hemiheptahydrate
- International non-proprietary name (INN) or common name
- dantrolene sodium, hemiheptahydrate
- Therapeutic area (MeSH)
- Malignant Hyperthermia
- Anatomical therapeutic chemical (ATC) code
- M03CA01
Pharmacotherapeutic group
MUSCLE RELAXANTSTherapeutic indication
In combination with adequate support measures, Agilus is indicated for the treatment of malignant hyperthermia in adults and children of all ages.
News on Agilus
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